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BETOPTIC

NDA

BETAXOLOL HYDROCHLORIDE | N019270 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension NCT02617459	Phase 3	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	366	2019-01-04 → 2021-07-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$8.74

per ml

Lowest NADAC/Unit

$8.69

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314024501BETAXOLOL HCL 0.5% EYE DROP	$8.74	ML	Generic	—	2026-06-17
61314024503BETAXOLOL HCL 0.5% EYE DROP	$8.69	ML	Generic	—	2026-01-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$20.28

Highest Price

$63.97

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61314-0245-01BETAXOLOL HCL 0.5% SOLN,OPH	$20.28	FSS	Sandoz, Inc.	08/14/2028
61314-0245-02BETAXOLOL HCL 0.5% SOLN,OPH	$63.97	FSS	Sandoz, Inc.	08/14/2028
61314-0245-03BETAXOLOL HCL 0.5% SOLN,OPH	$47.39	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

LUSOCHIMICA SPABETAXOLOL HYDROCHLORIDE

DMF 107271994

OLON SPABETAXOLOL HYDROCHLORIDE

DMF 172352004

INDOCO REMEDIES LTDBETAXOLOL HYDROCHLORIDE USP

DMF 253012011

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL

DMF 38001980

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL HYDROCHLORIDE

DMF 54641984

FINORGA SASInactiveBETAXOLOL HYDROCHLORIDE

DMF 62861986

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveBETAXOLOL HYDROCHLORIDE, USP

DMF 126381997

SIFAVITOR SRLInactiveBETAXOLOL HYDROCHLORIDE

DMF 126801997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 22, 2006	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Aug 30, 1985

No patent or exclusivity listings for this strength.